Russia faces several obstacles to mass production of Sputnik V – economic, financial and trade news

The Russian Sputnik V vaccine was designed in a state laboratory with support from the Kremlin sovereign wealth fund. But to reach the goal of vaccinating nearly a tenth of the world’s population, Moscow must turn to factories in Brazil, India and South Korea.

As the manufacturing capacity of your country is limited, the Russian Direct Investment Fund (RDIF), which manages the distribution of Sputnik V, has visited partner countries that are able to produce large quantities of the drugs.

It has thus entrusted the future of the vaccine to a large network of private subcontracting companies that operate under different national regulations. Some of these companies have counted Financial Times that it will take them months to reach their full production capacity.

Fourth flight to Moscow confirmed to bring more doses of Sputnik V vaccine

“Es probable that cada pas enfrente diferentes tipos de problemas… Lleva tiempo poner en marcha la produccin y guaranteeizar la calidad, especialmente cuando se terceriza la fabricacin”, dijo Rasmus Bech Hansen, fundador of Airfinity, una empresa de anlisis cientfico con sede In London.

The RDIF fund tells FT it has signed contracts with 15 manufacturers in 10 countries to produce 1.4 billion vaccines, enough to immunize 700 million people.

In this way, RDIF relies on foreign factories to produce more than double the doses manufactured in Russian companies. Factories in China, South Korea, India and Iran will manufacture vaccines that can be exported to third countries, while establishments located in countries such as Brazil and Serbia will primarily serve domestic demand.

“We have players who are really big and who will produce for the whole world. And we have smaller players who will produce more for local demand,” said Kirill Dmitriev, director of RDIF. “This is our strategy: to solve the problem of greater production and at the same time provide local availability.”

After independent scientific approval, Sputnik V could be manufactured in the country

The RDIF fund is confident that this decentralized strategy will help it avoid the production shortfalls that have plagued other COVID-19 vaccine manufacturers, such as AstraZeneca, and at the same time, it enjoys a large market for its vaccine in the poorest countries.

Russian state television proclaimed in November last year that the two-dose adenovirus vaccine is “as simple and reliable as the Kalashnikov rifle.” However, experts in many Western countries were skeptical of the lack of peer-reviewed evidence.

But after a study published earlier this month claimed the vaccine was 91.6% effective – on par with BioNTech / Pfizer and Moderna messenger RNA vaccines – Sputnik V is now seeking to mimic Kalashnikov as the one of the major Russian exports.

While messenger RNA vaccines must be stored at very low temperatures, which makes them difficult and more expensive to transport, Sputnik V is less expensive ($ 10) and requires 2-8 ° C to store, making it less expensive. makes it attractive to many low-income countries.

“He wins in every way,” says Dmitry Kulish, professor at Moscow’s Skoltech private scientific university. “The simplicity of the Sputnik V and its temperature sensitivity allow it to win like the Kalashnikov did.”

Moscow presents the vaccine for state development as a statement of scientific prowess and a tool of diplomatic power.

But Questions remain as to how quickly Sputnik V’s global production network will be able to meet demand from more than 50 countries. Entrepreneurs in India and Brazil, countries which account for more than half of the RDIF’s projected global production, told FT they have yet to start mass production of the vaccine.

Straight drugs, Indian manufacturer hired to produce over 100 million doses per year awaits approval from national regulators and then start cultivating the virus on a large scale, a step before production that takes a considerable amount of time, said a company close to FT.

Uniao Qumica, the company under contract with RDIF, said it is in a pilot phase of production and it will not be until April that it will reach full production capacity of 8 million monthly doses.

South Korean manufacturer GL Rapha, which produces exclusively for export, said it did not have the capacity for the 150 million annual doses agreed with the RDIF fund, it therefore subcontracted production to other companies and expanded its own facilities.

Airfinity estimates that 8 million doses of Sputnik V. have been delivered to date. U.S. drug maker Pfizer said this month it had produced 65 million doses.

Referring to RDIF’s vaccination target, Hansen said that “700 million is very high and unlikely given the current rate and also what we have seen from other vaccine producers.” And he added: “We think it is more realistic to talk about a total production of 380 million by 2021.but it could be significantly lower if its production center in Hyderabad, India, did not grow rapidly. “

However, the experience of Russian producers and the relative simplicity of the vaccine could allow foreign participants to rapidly increase their production, Kulish said

Dmitriev declined to comment on current production levels, but said RDIF will announce full details of overseas manufacturing next month.

“A few [de las fbricas extranjeras] are already producing. And most of them produced high quality test lots, “he noted.” In some of these countries, [las vacunas] they are ready to ship, others are in the process of being approved. “

In Russia, six pharmaceutical companies are making the vaccine, while two more are in talks to join them. This production is intended “almost 100%” for internal use.Dmitriev said, but began to shift to export markets after June when Russia’s needs were met.

Russian production has not been without setbacks. Initially, the country planned to manufacture 30 million doses by the end of 2020, but reduced its plans to just 2.5 million after local producers had problems purchasing equipment and producing the second dose of the vaccine. Dmitriev said these issues have already been resolved. Russia plans to manufacture 33 million doses by the end of March.

RDIF has declared its readiness to supply directly to the EU and has started submitting information to the European Medicines Agency (EMA), which approves drugs for use in the block. Josep Borrell, EU foreign policy chief, said during a recent visit to Moscow that he expected the EMA to approve Sputnik V “because we are facing a vaccine shortage” .

German Chancellor Angela Merkel said last month that her country was interested in “co-producing” Sputnik V if the EMA approved it. Dmitriev added: “We have several factories in the EU ready to work with us, ready to operate as soon as there is an approval.”

Traduccin: Mariana Oriolo